Dental Restoration, PermanentNCT02764450
10 Years Evaluation of Composite Restoration
A study testing Astralis 10 HPM and Astralis 10 RM in people with Dental Restoration, Permanent, run by BNM Clinic and Research.
Trial summary
This randomised, split-mouth clinical study evaluated the marginal quality of direct Class I and Class II restorations made of microhybrid composite and applied using two polymerisation protocols, Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Restoration, Permanent
- What is being tested?
- Astralis 10 HPM and Astralis 10 RM
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Apr 2004to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- subjects at least 18 years old,
- require restorations due to primary caries in contralateral quadrants with opposing and adjacent tooth contact,
- having no restoration in the antagonist,
Who cannot join
- allergic to resin-based materials,
- pregnant or nursing,
- periodontal disease
About this study
Official title: Marginal Quality of Posterior Microhybrid Resin Composite Restorations Applied Using Two Polymerisation Protocols
This randomised, split-mouth clinical study evaluated the marginal quality of direct Class I and Class II restorations made of microhybrid composite and applied using two polymerisation protocols,
- Conditions
- Dental Restoration, Permanent
- Being tested
- Astralis 10 HPM, Astralis 10 RM
- Keywords
- composite, restoration, polymerization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Astralis 10 HPMDevice
The cavity to be filled is in quadrant I or III
Astralis 10 RMDevice
The cavity to be filled is in quadrant II or IV
| Study group | Role | What they receive |
|---|---|---|
| Astralis 10 HPM | Experimental | Polymerization High-power mode: 1300 mW/cm2 for 10 s Receives: Device: Astralis 10 RM |
| Astralis 10 RM | Experimental | Polymerisation regular mode: 650 mW/cm2 for 20 Receives: Device: Astralis 10 HPM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cavity filled with problem in marginal adaptation and in marginal discoloration
Marginal quality of posterior microhybrid resin composite restorations applied using two polymerisation protocols: 5-year randomised split mouth trial.
The evaluation was done using both SQUACE and USPHS criteria
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study startApr 2004
- Primary completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental Restoration, PermanentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- BNM Clinic and Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Barabanti, BNM Clinic and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02764450
- Sponsor's protocol ID
- TEX-10y-2016
- Status last verified
- May 2016
- First submitted
- 8 Apr 2016
- Last updated
- 6 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Barabanti N, Gagliani M, Roulet JF, Testori T, Ozcan M, Cerutti A. Marginal quality of posterior microhybrid resin composite restorations applied using two polymerisation protocols: 5-year randomised split mouth trial. J Dent. 2013 May;41(5):436-42. doi: 10.1016/j.jdent.2013.02.009. Epub 2013 Feb 27.
PubMed 23454329
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Marginal Quality of Posterior Microhybrid Resin Composite Restorations Applied Using Two Polymerisation Protocols
- ClinicalTrials.gov ID
- NCT02764450
- Acronym / sponsor ID
- TEX-10y-2016
- Conditions
- Dental Restoration, Permanent
- Keywords
- composite, restoration, polymerization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- BNM Clinic and ResearchUniversity, hospital or other
- Study start
- Apr 2004
- Primary completion
- Mar 2015 (actual)
- First posted
- 6 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomised, split-mouth clinical study evaluated the marginal quality of direct Class I and Class II restorations made of microhybrid composite and applied using two polymerisation protocols,
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Astralis 10 HPM | Experimental | Device: Astralis 10 RMPolymerization High-power mode: 1300 mW/cm2 for 10 s |
| Astralis 10 RM | Experimental | Device: Astralis 10 HPMPolymerisation regular mode: 650 mW/cm2 for 20 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- subjects at least 18 years old,
- require restorations due to primary caries in contralateral quadrants with opposing and adjacent tooth contact,
- having no restoration in the antagonist,
Key exclusion criteria (3 listed)
- allergic to resin-based materials,
- pregnant or nursing,
- periodontal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Astralis 10 HPMThe cavity to be filled is in quadrant I or III | Device | Astralis 10 RM |
| Astralis 10 RMThe cavity to be filled is in quadrant II or IV | Device | Astralis 10 HPM |
Primary outcome
Number of cavity filled with problem in marginal adaptation and in marginal discoloration
Time frame: 5 years
Marginal quality of posterior microhybrid resin composite restorations applied using two polymerisation protocols: 5-year randomised split mouth trial. The evaluation was done using both SQUACE and USPHS criteria
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2016.
- Background: PubMed 23454329Barabanti N, Gagliani M, Roulet JF, Testori T, Ozcan M, Cerutti A. Marginal quality of posterior microhybrid resin composite restorations applied using two polymerisation protocols: 5-year randomised split mouth trial. J Dent. 2013 May;41(5):436-42. doi: 10.1016/j.jdent.2013.02.009. Epub 2013 Feb 27.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Astralis 10 HPM and Astralis 10 RM in people with Dental Restoration, Permanent, run by BNM Clinic and Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cavity filled with problem in marginal adaptation and in marginal discoloration (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02764450, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2016.